About CAPA Requests

CAPA requests are created to record recurring problems that companies encounter on their products and processes. The CAPA request management process is a method to record, review, and filter these requests for creating CAPAs.

This page discusses:

See Also
Creating a CAPA Request

CAPA Requests

CAPA requests can be created directly from the CAPA and Audit Management app. CAPA requests can also be created from complaints, events, Equipment Service Requests (ESR), Non-conformance Reports (NCR), and audit findings.

A CAPA request contains information about the type of the CAPA, type of the source through which the problem was identified, and the scope of the problem.

Any user with access to the CAPA and Audit Management app can create a CAPA request and submit it for review to the concerned organization. A Quality Manager from the organization can accept, review, and approve the CAPA request and assign it to a Project Lead. The Project Lead can create a CAPA using the approved CAPA request.

Lifecycle

The lifecycle of a CAPA request consists of seven states.

  • Preliminary: In this state, you can transfer, delete, or modify a CAPA request. You can also send the CAPA request for review.
  • Requested: A CAPA request is moved to this state if you submit it for review without specifying a reviewer. A Quality Manager can accept a CAPA request in this state for review.
  • Review: A CAPA request is moved to this state if you submit it for review to a specific reviewer or when a Quality Manager accepts it from the Requested state. In this state, you can approve or reject the CAPA request. You can set the CAPA request as a duplicate of another CAPA request. If required, you can send the CAPA request to the creator asking to provide more information.
  • Approved: In this state, you can create a CAPA using the CAPA request.
  • Committed: The CAPA request is moved to this state when a CAPA is created using the CAPA request.
  • Fulfilled: The CAPA request is moved to this state when the corresponding CAPA is in the Complete state.
  • Not Approved. The CAPA request is moved to this state if you reject the CAPA request during review.

When a CAPA request is set as a duplicate, it is moved to the Duplicate state.